Collagen-Hi-Light - Integra Miltex

HeliTape
Indications
• Used for dressing minor wounds
• Used to aid in the closure of graft sites
• Used to help repair the Schniderian Membrane
DESCRIPTION
The Absorbable Collagen Wound Dressings for Dental Surgery (HeliTape,
HeliCote, HeliPlug) are soft, white, pliable, nonfriable sponges. Because of the
coherent sponge structure, application of the dressings to the wound is easily
controlled. The dressings retain their structural integrity even when wet.
Unwanted dispersal from the site is not encountered.
The Absorbable Collagen Wound Dressings for Dental Surgery are very porous.
Greater than 90% of the dressing consists of open pores, which can fill with fluid.
The dressings are highly absorbent, holding many times their own weight of
saline solution.
The basic material from which the Absorbable Collagen Wound Dressings for
Dental Surgery are fabricated is collagen obtained from bovine deep flexor
(Achilles) tendon.The tendon is one of the purest sources of collagen that can
he readily obtained and processed in commercial quantities. Because of the high
initial purity and further processing achieved during manufacture, the sponges
are safe and effective wound dressings that exhibit very consistent behavior.
The Absorbable Collagen Wound Dressings for Dental Surgery are nontoxic and
nonpyrogenic, and each dressing is packaged individually. The sterility of the
dressing is guaranteed unless the package is opened or damaged
INDICATIONS
The Absorbable Collagen Wound Dressings for Dental Surgery are indicated for
application to moist or bleeding clean oral wounds created during dental
surgery, to control bleeding and protect the surface of the wound from further
injury. Topical administration of the Absorbable Collagen Wound Dressings
directly over the wound effectively controls bleeding usually within two to
five minutes.
The Absorbable Collagen Wound Dressings for Dental Surgery, are intended for
use on moist or bleeding wounds where a stabilized blood clot can help protect
the surface of the wound from further injury.The Absorbable Collagen Wound
Dressings are indicated during prolonged dental procedures where maintaining
a clear surgical field and ease of use are beneficial factors in treating oral wounds.
In situations where frequent aspiration is required to remove accumulated blood
and exudate, the Absorbable Collagen Wound Dressings can be used to dress
bleeding or oozing wounds and thereby improve patient comfort. Since the
Absorbable Collagen Wound Dressings can be easily removed without damaging
the wound bed, they can be used as temporary dressings prior to surgical closure.
INFORMATION FOR USE
The Absorbable Collagen Wound Dressings for Dental Surgery have been shown
to have good adherence to moist wounds.The highly porous sponge structure
absorbs blood and wound exudate.An inherent property of native collagen is the
ability to promote hemostasis. In contact with blood, collagen is known to cause
aggregation of platelets, which bind in large numbers to the collagen fibrils.The
aggregated platelets degranulate, releasing coagulation factors that enable,
together with plasma factors, the formation of Fibrin. The sponge structure of
the Absorbable Collagen Wound Dressings provides a three-dimensional matrix
for additional strengthening of the blood clot.
In vivo studies using guinea pigs showed that the incidence of infection (abscess)
of incision sites inoculated with Staphylococcus aureus was not enhanced by the
Manufactured by:
Integra LifeSciences Corporation
311 Enterprise Drive
Plainsboro, NJ 08536
HeliCote
Indications
• Used in palatal donor sites
• Used in mucosal flaps
DIRECTIONS FOR USE
Distributed by:
Miltex, Inc.
York, PA 17402
www.miltex.com
866-884-8300
HeliPlug
Indications
• Used to control bleeding and develop
blood clots in extraction sites
• Used to control bleeding and develop
blood clots in biopsy sites
presence of the Absorbable Collagen Wound Dressings when compared to another
collagen hemostatic agent. However, extent of wound infection tended to be greater
than control with the Absorbable Collagen Wound Dressings and another collagen
hemostatic agent tested.This tendency is observed with many foreign substances.
The Absorbable Collagen Wound Dressings for Dental Surgery have been tested for
potential allergenic sensitivity and cytotoxicity. The sponges contain no toxic
leachables, do not produce tissue irritation, and show no contact sensitization upon
repeat challenge. Passive hemagglutination, which is a sensitive test for potential
antigenicity, was used with the Absorbable Collagen Wound Dressings as the antigen.
There was no agglutination observed.
The Absorbable Collagen Wound Dressings for Dental Surgery are tested and certified
as nonpyrogenic.
PRECAUTIONS
The Absorbable Collagen Wound Dressings for Dental Surgery should not be used on
infected or contaminated wounds.
Although the Absorbable Collagen Wound Dressings will promote hemostasis, they
are not intended for use in treating systemic coagulation disorders.
Store the Absorbable Collagen Wound Dressings in scaled packages at room
temperature. Avoid excessive heat or humidity.
Discard all open but unused dressings. Do not attempt to re-sterilize.
The material has not been tested on pregnant women. The risk to health has not
been established.
The long-term effects of leaving the Absorbable Collagen Wound Dressings in situ are
presently unknown.
ADMINISTRATION
A sufficiently large Absorbable Collagen Wound Dressing should be selected so as to
completely cover the oral wound.The wound should be rinsed clean and excess fluid
removed. The dressing should be applied over the wound and held in place with
moderate pressure.The period of time necessary to apply pressure will vary with the
degree of bleeding. In general, two to five minutes should be sufficient to achieve
hemostasis.
At the end of the procedure, the Absorbable Collagen Wound Dressing can be
removed, replaced or left in situ. If desired, the Absorbable Collagen Wound Dressing
can be covered with a periodontal packing to help hold the sponge in place. The
Absorbable Collagen Wound Dressing may be left in situ, when necessary. However,
the dentist should remove any excess dressing prior to wound closure.
ADVERSE REACTIONS
Adverse reactions reported with another microfibrillar collagen hemostatic agent that
were possibly related to its use were adhesion formation, allergic reaction, foreign
body reaction and subgaleal seroma (report of a single case).
Since the wound dressings are collagen-based products, adverse reactions experienced
with another microfibrillar collagen may be related.
The Absorbable Collagen Wound Dressings for Dental Surgery differ substantially in
source, method of processing, and purity from other microfibrillar and macrofibrillar
forms of collagen commercially distributed for hemostatic and wound
care applications.
HeliCote, HeliPlug, HeliTape and Miltex Redefining Excellence are
trademarks of Integra LifeSciences Corporation or its subsidiaries.
Miltex is a registered trademark of Integra LifeSciences
Corporation or its subsidiaries.